PK, bioavailability, excretion & metabolites of BMS-927711 (QBR113048)

• Research type

  Research Study

• Full title

  A Two-Part, Sequential Design Study to Determine BMS-927711 Pharmacokinetics, Absolute Oral Bioavailability, Mass Balance Recovery and Metabolite Profiling in Healthy Male Subjects

• IRAS ID

  107469

• Contact name

  Philip Evans

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2012-001907-19

• Research summary

  The Sponsor is developing the study drug, BMS-927711, for the potential treatment of migraine. The study will try to identify the pharmacokinetic (PK) profile (how the drug is absorbed into the bloodstream), the absolute oral bioavailability (how much of the drug is absorbed into the bloodstream from a dose via the mouth compared to a dose given directly into the bloodstream), the mass balance recovery (how/where the drug is excreted from the body), and perform metabolite profiling (work out how the drug is broken down by the body and what the breakdown products are) of the study drug. This study will dose BMS-927711 at 300 mg to healthy male subjects over two study periods. In Period 1, the subjects will be dosed with 300 mg of BMS-927711 orally (by mouth) and then with an intravenous (IV) radiolabelled 100 æg infusion of [14C]-BMS-927711, which will be administered directly into the vein. In Period 2, the subjects will be dosed with a radiolabelled oral solution of 300 mg of [14C]-BMS-927711.

• REC name

  Scotland A REC

• REC reference

  12/SS/0104

• Date of REC Opinion

  18 Jul 2012

• REC opinion

  Further Information Favourable Opinion